Edwards Lifesciences Associate Manager, Clinical Research Monitoring (Remote, US Field-Based) in New York City, United States
As an Associate Manager, Clinical Research Monitoring, you manage a team of clinical researching monitoring professionals and clinical-related activities.
Manage and/or lead a small team within assigned function including team budget responsibilities and managing outside contractors/vendors. Develop team members to increase business acumen and functional skills
Provide input on strategic direction on field monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site), act as a Core Team lead, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
Lead in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities Act as a mentor to new or junior level employees
Oversee clinical trial conduct including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence
Participate and contribute to the development of Provide input on clinical protocols, and informed consent forms, and case report forms
Participate in development and validation of case report forms
Review monitoring visit reports
Resolve complex trial/study data and regulatory documentation discrepancies escalated by junior level employees
Review and complete checklist on informed consent forms (ICF)
Provide direction and guidance to execute project deliverables in collaboration with project managers
Identify and evaluate clinical process improvement opportunities
Bachelor's Degree or equivalent in related field
Minimum of 10 years of Clinical Research experience inclusive of Field Monitoring experience and Clinical Trial Management, Quality Assurance/Control or Regulatory Compliance experience obtained from medical device or pharmaceutical industries, or CRO
Successful hire will have demonstrated track record of people management experience and strong leadership and coaching ability
Master's degree or equivalent
Clinical Research Certification (ACRP or SoCRA preferred)
Proven successful project management leadership skills
Proven expertise in MS Office Suite, including Word, Excel, and Adobe
Experience with electronic data capture preferred
Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
Excellent problem-solving, organizational, analytical and critical thinking skills
Extensive understanding of clinical studies procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own discipline
Extensive understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
Demonstrated skill set to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
Primarily interacts with internal subordinates and other supervisors
Typically interacts with external suppliers, vendors and/or customers
Share information and provides basic problem solving solutions; gains cooperation of others, conducts presentations of technical information concerning specific projects or schedules
Dedicated to quality client service and pro-active and responsive to client needs.
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
For Colorado Residents Only:
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
The base pay range for this position is $117,000 to $137,000
Additional information can be found through the link below:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.